ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE Reprocessing Manual

Contents

Contents Chapter 1 General Policy ... 1 1.1

Instructions ... 1

1.2

Importance of reprocessing ... 2

1.3

Signal words ... 2

1.4

Precautions ... 3

1.5

Reprocessing before the first use ... 6

1.6

Reprocessing and storage after use ... 6

1.7

Reprocessing before patient procedure ... 7

Chapter 2 Function and Inspection of the Accessories for Reprocessing ... 9 2.1

Sterilization cap (MAJ-1538) ... 9

Chapter 3 Compatible Reprocessing Methods and Chemical Agents ... 11 3.1

Compatibility summary ... 11 Microbiological efficacy ... 12 Material durability ... 12 List of compatible methods validated in terms of microbiological efficacy and material durability ... 13 List of compatible methods validated in terms of material durability ... 13

3.2

Water (for reprocessing) ... 15

3.3

Detergent solution ... 15

3.4

Disinfectant solution ... 15

3.5

Rinse water ... 16

3.6

Ethylene oxide gas sterilization ... 16

Chapter 4 Reprocessing Workflow for the Endoscope and Accessories ... 19 4.1

Summary of reprocessing workflow ... 19

4.2

Workflow for manually cleaning and sterilizing the endoscope and accessories ... 20

LTF-190-10-3D REPROCESSING MANUAL

i

Contents

Chapter 5 Reprocessing the Endoscope ... 21 5.1

Summary of reprocessing the endoscope ... 21

5.2

Preparing the equipment for reprocessing ... 22 Equipment needed ... 22

5.3

Precleaning the endoscope ... 24 Equipment needed ... 24 Preparation ... 24 Wipe the insertion section ... 24

5.4

Leakage testing of the endoscope ... 25 Equipment needed ... 25 Detach the endoscope from the video system center ... 26 Detach the endoscope from the light source ... 26 Perform the leakage test ... 27

5.5

Manually cleaning the endoscope ... 32 Equipment needed ... 32 Clean the external surface ... 32 Immerse the endoscope in detergent solution ... 33 Remove detergent solution from the endoscope ... 33 Dry external surfaces ... 33

5.6

Manually disinfecting the endoscope ... 34 Equipment needed ... 34 Preparation ... 34 Immerse the endoscope in disinfectant solution ... 35 Remove the endoscope from disinfectant solution ... 35

5.7

Rinsing the endoscope following disinfection ... 36 Equipment needed ... 36 Rinse the endoscope ... 36

5.8

Sterilizing the endoscope ... 37 Ethylene oxide gas sterilization of the endoscope ... 37

5.9

Presoaking the endoscope ... 39 Equipment needed ... 39

Chapter 6 Storage and Disposal ... 41

ii

6.1

Precautions for storage and disposal ... 41

6.2

Storing the sterilized endoscope and accessories ... 42

6.3

Disposal ... 42

LTF-190-10-3D REPROCESSING MANUAL

1.1 Instructions

Chapter 1 1.1

General Policy

Ch.1

Instructions • This manual contains the reprocessing methods recommended by Olympus for the endoscope and accessories listed on the front cover. • This instruction manual contains essential information on reprocessing the endoscope and accessories safely and effectively. • Before reprocessing, thoroughly review this manual and the manuals of the reprocessing equipment and chemicals that will be used for reprocessing. Reprocess all the devices as instructed. • Note that the complete instruction manual set for the endoscope and accessories consists of this manual and the “OPERATION MANUAL” with your endoscope model listed on the cover. Both manuals accompanied the endoscope at shipment. • Keep this manual and all related manuals in a safe and accessible location (e.g., in the reprocessing area). • If you have any questions or comments about any information in this manual, or if a problem that cannot be solved occurs while reprocessing, contact Olympus.

 Terms used in this manual Disinfection Some countries classify the disinfection level and define “high-level disinfection”, and other countries do not. The term “disinfection” is used, including meaning “high-level disinfection”, in this manual. For disinfectant solution, follow the instructions as described in Section 3.4, “Disinfectant solution”.

LTF-190-10-3D REPROCESSING MANUAL

1

1.2 Importance of reprocessing

Ch.1

1.2

Importance of reprocessing

The medical literature reports incidents of cross-contamination resulting from improper reprocessing. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals of all ancillary equipment, and have a thorough understanding of the following items: • Professional health and safety policies of your hospital • Instruction manuals for the endoscope, accessories, and all the other reprocessing equipment • Structure and handling of the endoscope and accessories • Handling of pertinent chemicals When selecting appropriate methods and conditions for cleaning and disinfection and sterilization, follow the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices, in addition to the instructions given in this manual.

1.3

Signal words

The following signal words are used throughout this manual:

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

2

Indicates additional helpful information.

LTF-190-10-3D REPROCESSING MANUAL

1.4 Precautions

1.4

Ch.1

Precautions WARNING • An insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who contact them. • The video system center, light source, and/or front panels of equipment may cause an infection control risk. Perform proper cleaning and disinfection as described in their respective instruction manuals. Also, a tap and/or basin that medical personnel come in contact with may cause an infection control risk as well. Perform proper replacement, cleaning, and disinfection. • All disinfection methods and all sterilization methods require thorough cleaning prior to the instrument being reprocessed. If the instruments are not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope. • All accessories used with the endoscope during the patient procedure must be reprocessed after each patient procedure, even if the accessories were not used during the patient procedure. Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators. • Residual disinfectant solution may cause adverse reactions in patients. Therefore, rinse all external surfaces and channels of the endoscope and accessories thoroughly with water to remove residual disinfectant solution after disinfection. • The results of sterilization depend on various factors. These factors include how the equipment was packaged and the placing and loading of the package in the sterilization device. Verify the sterilization process using biological and/or chemical indicators. Follow the guidelines for sterilization issued by national authorities, professional organizations and infection control professionals, including the frequency of the above verification, as well as the instruction manual for the sterilization device. • Establish an internal system of identifying contaminated versus reprocessed endoscopes and accessories to prevent both mix-ups and cross-contamination. Some national or professional guidelines recommend separating dirty (contaminated) area, clean area, and storage area. Touching a reprocessed endoscope and/or accessories with contaminated gloves or placing them on a contaminated hanger or surface, including letting them touch the floor, will recontaminate them. • Prior to each patient procedure, confirm that the endoscope and accessories have been properly reprocessed and stored. If there are any doubts or questions, reprocess them again before the patient procedure, following the instructions given in this manual. LTF-190-10-3D REPROCESSING MANUAL

3

1.4 Precautions

Ch.1

WARNING • Perform a leakage test on the endoscope after each precleaning procedure. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions. Use of a leaking endoscope may also pose an infection control risk. Leakage tester

Figure 1.1 • Store alcohol in an airtight container. Alcohol stored in an open container may cause a fire hazard and may result in a loss of efficacy due to evaporation. • The accessories listed on the front cover of this manual cannot be refurbished or repaired and are intended to be replaced once they show any signs of wear and tear. Should any irregularity be observed, use a replacement accessory instead. Using defective accessories may cause equipment malfunction, reduce the efficacy of reprocessing, present a risk to patients and/or operators, or damage the endoscope and/or accessories. • Patient debris and used reprocessing chemicals pose infection control risks. To guard against contact with dangerous chemicals and potentially infectious material, wear appropriate personal protective equipment during reprocessing. Such protective equipment should include appropriate eyewear, face mask, cap, moisture-resistant clothing, shoe covers, and chemical-resistant gloves that fit properly and are long enough to prevent skin exposure. • The reprocessing room must be adequately ventilated to minimize the risks from chemical vapors. • Always remove contaminated personal protective equipment before leaving the reprocessing area to prevent contamination from spreading. • Instructions provided in this manual are not valid for Olympus devices repaired by a non-Olympus facility. The Olympus recommended reprocessing procedures have not been validated for reprocessing devices repaired by a non-Olympus facility. In the event that your device has been repaired by a non-Olympus facility, contact that repair facility for instructions regarding reprocessing.

4

LTF-190-10-3D REPROCESSING MANUAL

1.4 Precautions

Ch.1

WARNING • Prions, which are the pathogenic agents of the Creutzfeldt-Jakob disease (CJD) cannot be destroyed or inactivated by the reprocessing methods stated in this instruction manual. When using the endoscope and accessories on patients with CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use them for such patients only, or immediately dispose of them after use in an appropriate manner to prevent the usage of exposed devices on other patients. For methods to handle CJD, follow the respective guidelines in your country. • The endoscope and accessories may be damaged by published methods for destroying or inactivating prions. For information on the durability of Olympus equipment against a particular reprocessing method, contact Olympus. In general, Olympus cannot guarantee the effectiveness, safety, and durability of reprocessing methods not described in this reprocessing manual. If you choose to use a reprocessing method not recommended in this manual, the local institution and/or physicians must assume responsibility for its safety and efficacy. Make sure to carefully inspect each piece of endoscopic equipment for irregularities (damage) prior to each patient procedure. Do not use the equipment if any irregularity is found. • Good quality control practices typically require appropriate documentation. Items such as local SOPs (Standard Operating Procedures), confirmation of operator training, routine testing of the disinfectant’s MEC (Minimal Effective Concentration), confirmation of the disinfectant’s use-life, etc. should be documented as performed.

CAUTION • Before immersing the endoscope in reprocessing fluids, confirm that the sterilization cap (MAJ-1538) is not attached to the endoscope. If the sterilization cap is attached, the reprocessing fluids will be able to penetrate into the endoscope, and it can be damaged. • Store spare accessories in their original packaging to prevent damage. • To prevent damage, do not apply excessive force to the endoscope and accessories during reprocessing. • Vapors from disinfectant solution and alcohol may damage electronic devices such as computers. Properly manage the quality and durability of the devices used in reprocessing rooms and the ventilation performance of the rooms. • Do not steam sterilize the endoscope. The endoscope is damaged. • The endoscope is incompatible with the automatic thermal cleaning/disinfector. The endoscope is damaged.

LTF-190-10-3D REPROCESSING MANUAL

5

1.5 Reprocessing before the first use

Ch.1

1.5

Reprocessing before the first use

New endoscopes, repaired endoscopes, accessories, and the carrying case for endoscopes are not reprocessed prior to shipping from Olympus, regardless of whether those instruments are for new purchase, demo, or loaner purposes. Reprocess all such endoscopes and accessories received from Olympus according to the instructions given in this manual before storage and before using them in a patient procedure.

1.6

Reprocessing and storage after use WARNING • Do not reuse rinse water. • Disinfectant solution is only effective when used according to the disinfectant manufacturer’s instructions. Follow the manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time and use life required to achieve disinfection. • If the disinfectant solution is reused, check its efficacy by proper methods, such as using test strip, according to the disinfectant manufacturer’s recommendations prior to use. • To maintain sterility of equipment following sterilization, use sterile packaging and wraps according to national guidelines.

6

LTF-190-10-3D REPROCESSING MANUAL

1.7 Reprocessing before patient procedure

1.7

Ch.1

Reprocessing before patient procedure WARNING • Improper storage practices, such as not thoroughly drying external surfaces prior to storage, will lead to an infection control risk. • Improper handling, such as touching a reprocessed endoscope and/or accessories with contaminated gloves, placing a reprocessed device on a contaminated hanger or surface, allowing devices to touch the floor, etc. will recontaminate the device.

NOTE Some national or professional guidelines recommend reprocessing endoscopes prior to their first use of the day. Confirm that the endoscope and accessories have undergone proper reprocessing following their last use and that they have been stored properly. Check the storage period of reprocessed endoscopes, and check for surface contamination (e.g., dust). Check the expiration date marked on all items and check the sterile packaging for tears or breaches. If there are any doubts or questions concerning whether a device is contaminated, reprocess it again following the instructions given in this manual.

LTF-190-10-3D REPROCESSING MANUAL

7

1.7 Reprocessing before patient procedure

Ch.1

8

LTF-190-10-3D REPROCESSING MANUAL

2.1 Sterilization cap (MAJ-1538)

Chapter 2

Function and Inspection of the Accessories for Reprocessing

Ch.2

Certain accessories are required for reprocessing the endoscope. This chapter describes the function of these accessories. It also describes how to inspect these accessories before using them to reprocess the endoscope.

2.1

Sterilization cap (MAJ-1538)

Connector

Figure 2.1

 Function When performing gas sterilization (e.g., ethylene oxide gas sterilization, hydrogen peroxide low temperature plasma), the sterilization cap must be attached to the venting connector on the light guide connector. Venting connector

Sterilization cap

Figure 2.2

LTF-190-10-3D REPROCESSING MANUAL

9

2.1 Sterilization cap (MAJ-1538)

 Inspection Confirm that the sterilization cap is free from scratches, flaws, and debris.

Ch.2

10

LTF-190-10-3D REPROCESSING MANUAL

3.1 Compatibility summary

Chapter 3

Compatible Reprocessing Methods and Chemical Agents Ch.3

3.1

Compatibility summary

The endoscope and accessories are compatible with several methods of reprocessing. However, not all reprocessing methods are compatible with all endoscopes and all accessories. Reprocessing with incompatible methods can cause equipment damage even if the number of reprocessing cycles is small. For appropriate reprocessing methods, see Table 3.1 and 3.2. Follow the policies at your local institution when choosing which methods listed in Table 3.1 and 3.2 to employ.

CAUTION • Methods listed as “compatible” in Table 3.1 and 3.2 are compatible for routine use only when used according to manufacturer’s instructions. Repeated use and reprocessing of endoscopes and accessories lead to gradual wear and tear. Furthermore, reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration. In general, sterilization processes are harsher on equipment than disinfection processes. Before each patient procedure, inspect the endoscope and accessories for damage, according to the instructions described in this manual and its companion “OPERATION MANUAL”. • Instructions provided in this manual regarding material compatibility are not valid for Olympus devices repaired by a non-Olympus facility. Olympus repairs devices to manufacturer’s specifications using original equipment manufacturer’s (OEM) materials. The use of non-OEM materials to repair an Olympus device may affect the material compatibility of the device with certain reprocessing chemicals or methods. In the event that your device has been repaired by a non-Olympus facility, contact the repair facility for instructions regarding material compatibility. Olympus provides information regarding validated methods in terms of the following two criteria. − Microbiological efficacy − Material durability

LTF-190-10-3D REPROCESSING MANUAL

11

3.1 Compatibility summary

 Microbiological efficacy If it is stated that a method is “validated” in terms of microbiological efficacy, it means that instruments have been reprocessed successfully using the standardized method described in this manual.

Ch.3

 Material durability If it is stated that a method is “validated” in terms of material durability, it means that the method can be adopted as a repetitive reprocessing procedure. Just because the material durability is confirmed, it does not mean that a certain degree of microbiological effectiveness is guaranteed.

12

LTF-190-10-3D REPROCESSING MANUAL

3.1 Compatibility summary

 List of compatible methods validated in terms of microbiological efficacy and material durability For sterilization

Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide gas/80% CO2)

Ch.3

Ethylene oxide gas sterilization (100% ethylene oxide gas) For disinfection

2 – 3.5% glutaraldehyde

For cleaning

Detergent solution Ultrasonic cleaning

Endoscope

Sterilization cap (MAJ-1538)

compatible

not compatible

Table 3.1

 List of compatible methods validated in terms of material durability Low temperature steam and formaldehyde sterilization*1 STERRAD® 50/100S/200/NX *2 Endoscope *3 Sterilization cap (MAJ-1538)

*3

compatible

not compatible

Table 3.2 *1 This method may not be available in some areas. *2 ASP (Advanced Sterilization Products) tests the microbiological efficacy of Olympus products in sterility. As for the microbiological efficacy, contact ASP. Also, refer to the “STERRAD® 50/100S/200/NX” instruction manual. *3 For further details, contact Olympus.

LTF-190-10-3D REPROCESSING MANUAL

13

3.1 Compatibility summary

 STERRAD® 50/100S/200/NX CAUTION • When performing STERRAD® 50/100S/200/NX sterilization, the sterilization cap (MAJ-1538) must be attached to the venting connector.

Ch.3

Sterilization cap

Connecting the sterilization cap

Figure 3.1 • Sterilization by STERRAD® 50/100S/200/NX system may deteriorate the adhesive of the insertion section. Depending on the circumstances, replacement of the insertion section may be required. Before use, confirm that the endoscope is free from any damage or other irregularities. For further details, contact Olympus.

14

LTF-190-10-3D REPROCESSING MANUAL

3.2 Water (for reprocessing)

3.2

Water (for reprocessing)

Water is used for leakage testing and manual cleaning of the endoscope and accessories. For these purposes, use either fresh, potable water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality. Consult with your hospital’s infection control committee. When rinsing the endoscope and accessories following disinfection, use the water as described in Section 3.5, “Rinse water”.

3.3

Detergent solution WARNING • Excessive foaming prevents detergent solution from properly contacting the surfaces of the endoscope and accessories, and may impair effective cleaning. • Do not reuse detergent solution.

Use a medical-grade, low-foaming, neutral pH detergent that may or may not contain enzymes. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, and expiration date. Contact Olympus for the names of specific brands of detergent solution that have been tested for compatibility with endoscopes and accessories.

3.4

Disinfectant solution

Use a disinfectant cleared/approved by your national regulatory agency for use in reprocessing flexible endoscopes. If national or professional guidelines applicable to your institution define “high-level disinfection” and require using a high-level disinfectant for the flexible endoscopes, follow the requirement. Follow the disinfectant manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time, and expiration date. For further information regarding the compatibility of glutaraldehyde-based or non glutaraldehyde-based disinfectant solution, contact Olympus.

LTF-190-10-3D REPROCESSING MANUAL

15

Ch.3

3.5 Rinse water

3.5

Rinse water

Use sterile water for rinsing the endoscope and accessories following disinfection. If sterile water is not available, use either fresh, potable water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality. Consult with your hospital’s infection control committee regarding local policies on water quality.

Ch.3

3.6

Ethylene oxide gas sterilization

The endoscope and accessories listed as compatible with ethylene oxide gas sterilization in Table 3.1 can be sterilized by ethylene oxide gas and aerated within the parameters given in Table 3.3 and 3.4. When performing ethylene oxide gas sterilization, follow all national, professional and institutional reprocessing protocols as well as the instructions provided by the manufacturer of your sterilization equipment.

CAUTION • Attach the sterilization cap (MAJ-1538) to the endoscope before ethylene oxide gas sterilization. If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism.

Sterilization cap

Connecting the sterilization cap

Figure 3.2 • Exceeding the recommended parameters may cause equipment damage.

16

LTF-190-10-3D REPROCESSING MANUAL

3.6 Ethylene oxide gas sterilization

 Parameters for 100% ethylene oxide gas sterilization cycles Process phase Sterilization

Aeration

Parameter

Value

Temperature

55°C (130°F)

Vacuum (Absolute pressure)

0.05 – 0.07 MPa (7.25 – 10.15 psia)

Relative humidity

50 – 80%

Ethylene oxide gas concentration

0.735 – 0.740 mg/cm3 (735 – 740 mg/L)

Exposure time

60 minutes

Minimum aeration parameters

12 hours in an aeration chamber at 50 – 57°C (122 – 135°F) or 7 days at room temperature

Ch.3

Table 3.3

 Parameters for 20% ethylene oxide gas/80% CO2 gas sterilization cycles

Process phase Sterilization

Aeration

Parameter

Value

Temperature

55°C (130°F)

Relative pressure

0.1 – 0.17 MPa

Relative humidity

35 – 85%

Ethylene oxide gas concentration

0.6 – 0.7 mg/cm3 (600 – 700 mg/L)

Exposure time

2 – 4 hours

Minimum aeration parameters

12 hours in an aeration chamber at 50 – 57°C (122 – 135°F) or 7 days at room temperature

Table 3.4

LTF-190-10-3D REPROCESSING MANUAL

17